Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis

NCT03992261 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 122-0551-209
• Study Type: interventional
• Target: 24
• Locations: 4 countries
• Sites: 11

Brief Summary

The purpose of this study is to evaluate Halobetasol Propionate (HBP) foam, 0.05% in subjects aged 12 through less than 18 years with plaque psoriasis in order to check the safety, the potential to suppress the adrenal glands and the degree to which the drug is absorbed into the bloodstream.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Number of Subjects to Exhibit Adrenal Suppression as Measured by a Cosyntropin Stimulation Test

  A subject is considered to have adrenal suppression evidence if post cosyntropin stimulation lab draw result is less than or equal to 18.0 mcg/100 mL. HPA axis responses to cosyntropin were dichotomized to normal and abnormal. Cosyntropin stimulation testing was performed at Screening and Day 15 and approximately 4 weeks post-treatment if a subject's laboratory results at Day 15 showed an abnormal hypothalamic pituitary adrenal (HPA) axis response (HPA axis suppression). An abnormal HPA axis response was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at end of study (EOS).

  Screening, Day 15, and approximately 4 weeks post-treatment, an average of 28 days

• Plasma Concentration of HBP at Screening, Day 8 and Day 15

  Morning trough concentrations of HBP in plasma at Screening, Day 8, and Day 15 were summarized for the PK population using geometric mean, coefficient of variation in addition to n, mean, median, standard deviation (SD), minimum, and maximum.

  15 days

Study Arms (1)

Halobetasol Propionate Foam

EXPERIMENTAL

2 weeks of application, 2 times daily

Drug: Halobetasol Topical Foam

Interventions

Halobetasol Topical Foam DRUG

Foam

Also known as: HBP Foam

Halobetasol Propionate Foam

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject is male or non-pregnant female and is 12 to less than 18 years of age
• Subject has provided written informed assent and was accompanied by the parent or legal guardian at the time of assent/consent signing
• Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% Body Surface Area (BSA)
• Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit

You may not qualify if:

• Subject has spontaneously improving or rapidly deteriorating plaque psoriasis
• Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
• Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to an unacceptable risk by study participation
• Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation
• Subject is pregnant, lactating, or is planning to become pregnant during the study
• Subject is currently enrolled in an investigational drug or device study

Sponsors & Collaborators

• Mayne Pharma International Pty Ltd: lead

Study Sites (11)

Investigative Site 2

Hialeah, Florida, 33012, United States

Location

Investigative Site 1

Saint Joseph, Missouri, 64506, United States

Location

Investigative Site 9

Batumi, Georgia

Location

Investigative Site 10

Tbilisi, 0114, Georgia

Location

Investigative Site 11

Tbilisi, 0177, Georgia

Location

Investigative Site 3

Krakow, Poland

Location

Investigative Site 5

Tarnów, Poland

Location

Investigative Site 4

Warsaw, Poland

Location

Investigative Site 8

Rivne, Ukraine

Location

Investigative Site 6

Uzhhorod, Ukraine

Location

Investigative Site 7

Zaporizhzhya, Ukraine

Location

Results Point of Contact

• Title: Lee Ann McDowell, PharmD - Director of Medical Affairs
• Organization: Mayne Pharma

leeann.mcdowell@maynepharma.com

4124776681

Study Officials

• Daniel J Piacquadio, MD

  Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: June 14, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: July 6, 2023
• Results First Posted: July 6, 2023

Record last verified: 2023-03

Locations

PL (3); US (2); GE (3); UA (3)